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ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

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ClinicalTrials.gov Identifier: NCT04357717
Recruitment Status : Terminated (project reprioritization)
First Posted : April 22, 2020
Last Update Posted : March 31, 2022
Information provided by (Responsible Party):
Exosome Diagnostics, Inc.

Brief Summary:

The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy.

Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.

Condition or disease Intervention/treatment
Prostate Cancer Diagnostic Test: ExoDx Prostate

Detailed Description:

Primary Endpoint:

Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.

Secondary Endpoints (exploratory):

  1. Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.
  2. Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).
  3. Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy.
  4. Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of ExoDx™ Prostate (IntelliScore) in Men With Prior Negative Prostate Biopsy Presenting for a Repeat Biopsy
Actual Study Start Date : March 15, 2020
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Intervention Details:
  • Diagnostic Test: ExoDx Prostate
    Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml

Primary Outcome Measures :
  1. Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml and at least one prior negative prostate biopsy

Inclusion Criteria:

  • 50+ years of age
  • Clinical suspicion for prostate cancer
  • Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
  • At least one (1) prior negative prostate biopsy

Exclusion Criteria:

  • Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).
  • Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
  • History of prostate cancer.
  • History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
  • No known hepatitis status (all types) and/or HIV documented in patient's medical record.
  • Patients with history of concurrent renal/bladder tumors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357717

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United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21204
United States, New Jersey
New Jersey Urology
Voorhees, New Jersey, United States, 08043
Sponsors and Collaborators
Exosome Diagnostics, Inc.
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Responsible Party: Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT04357717    
Other Study ID Numbers: ECT2018-001
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exosome Diagnostics, Inc.:
ExoDx Prostate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases